FARAWAVE™ M004PF41M432Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506043223), received between Jan 27, 2026 and Mar 18, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

5 other recalls cover devices cleared under the same FDA submission (P230030); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ABLATION PROCEDURE, A FARAWAVE NAV CATHETER WAS SELECTED FOR USE. THE PHYSICIAN OBTAINED ACCESS, INSERTED A NON BOSTON SCIENTIFIC CATHETER, AND PERFORMED A RADIOFREQUENCY (RF) CTI (CAVOTRICUSPID ISTHMUS) LINE USING A NON BOSTON SCIENTIFIC ABLATION CATHETER. TRANSSEPTAL ACCESS WAS ACHIEVED WITH A VERSACROSS WIRE THROUGH A NON BOSTON SCIENTIFIC SHEATH. THE FARAWAVE CATHETER WAS THEN INSERTED, AND A PULMONARY VEIN ISOLATION WAS PERFORMED. APPROXIMATELY 15 MINUTES INTO ABLATION, WHILE THE CATHETER WAS IN THE RIGHT INFERIOR PULMONARY VEIN, A SMALL EFFUSION WAS NOTED. AFTER COMPLETING THE RIGHT SUPERIOR PULMONARY VEIN, THE EFFUSION HAD INCREASED IN SIZE. THE PHYSICIAN BELIEVED THE EFFUSION ORIGINATED FROM THE RIGHT ATRIUM, POTENTIALLY RELATED TO THE RF CTI LINE OR PLACEMENT OF THE NON BOSTON SCIENTIFIC CATHETER, RATHER THAN FROM THE LEFT ATRIUM OR THE FARAWAVE DEVICE. NO RESISTANCE WAS FELT WHILE MANEUVERING ANY CATHETERS. THE EFFUSION WAS DISCOVERED DURING ABLATION, NOT BEFORE OR AFTER THE PROCEDURE. A PERFORATION LOCATION WAS NOT CONFIRMED. TO MANAGE THE COMPLICATION, THE PATIENT UNDERWENT PERICARDIOCENTESIS, AND 700 ML OF FLUID WAS DRAINED. THE PATIENT WAS ADMITTED TO THE HO

  Patient problems: Pericardial Effusion

  MAUDE report 24626483 ↗
• MalfunctionJan 27, 2026Entrapment of Device

  IT WAS REPORTED THAT FOR AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A FARAWAVE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN NOTED THAT THE PHYSICIAN WAS UNABLE TO ADVANCE THE 0.035 ROSEN GUIDEWIRE THROUGH THE CATHETER AND REQUESTED ANOTHER CATHETER. THE GUIDEWIRE ABLE TO BE REMOVED BUT NOTICEABLE FORCE WAS NEEDED TO REMOVE THE GUIDEWIRE. THE GUIDEWIRE COULD NOT BE REMOVED AT THE TIME OF THE EVENT, HOWEVER. NO TISSUE WAS NOTED ON THE DEVICE. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194602 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P230030. One submission often covers many models, so check the product and lot details in each record.

• Z-2752-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
• Z-2753-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
• Z-2751-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
• Z-2750-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
• Z-2278-2025 · Jun 25, 2025 · Open, Classified
  FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401